Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040581
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/21/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/05/2024 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
05/28/2024 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
05/28/2024 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/16/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
PREDNISONE
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040581 | ENDO OPERATIONS |
PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 087801 | HIKMA |
PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208412 | STRIDES PHARMA |